AscitesNCT04245553
Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?
A study testing Abdominal Point of Care Ultrasound in people with Ascites and Paracentesis, run by Steven Montague at 1 site in Canada.
Trial summary
Paracentesis is a bedside procedure in which a needle is inserted into a patient's peritoneum in order to obtain ascitic fluid. This is a safe bedside procedure with very low risks of complications that is usually performed using physical exam maneuvers to determine the site of needle insertion. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ascites, Paracentesis, Point of Care Ultrasound (POCUS)
- What is being tested?
- Abdominal Point of Care Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants scheduled to have either a diagnostic of therapeutic paracentesis.
- Participants can be either inpatients under the care of general internal medicine, or outpatients under the care of gastroenterology or general internal medicine.
- Operators will be recruited on a volunteer basis and will include medical residents or subspecialty fellows with knowledge of POCUS for paracentesis purposes, either through core residency programs or more advanced training.
Who cannot join
- Loculated ascites
- Current anticoagulation
- Hemodynamic instability
- Bowel obstruction
- Pregnancy
- Abdominal wall cellulitis
- Platelet count <20
Trial locations and contacts
1 site in 1 country.
About this study
Paracentesis is a bedside procedure in which a needle is inserted into a patient's peritoneum in order to obtain ascitic fluid. This is a safe bedside procedure with very low risks of complications that is usually performed using physical exam maneuvers to determine the site of needle insertion. Point of care ultrasound (POCUS) technology has improved the safety of central venous catheter insertion and thoracentesis, yet the data on safety in paracentesis is equivocal. In a practical study, we aim to determine if POCUS will change the needle insertion site over the traditional anatomic landmarking method. Operators will landmark for paracentesis using conventional physical exam and then utilize POCUS to determine if there is a more optimal site. The primary endpoint will be whether POCUS yielded a change in the needle insertion site, as defined by a location greater than 5cm from the anatomic site, at least 20% of the time. The results will further our understanding of POCUS in improving procedural safety, thereby adding to the currently limited literature on this topic. Furthermore, this study will inform residency training programs about the utility in POCUS training for paracentesis and may advocate for the availability of POCUS devices to physicians performing this procedure.
- Conditions
- Ascites, Paracentesis, Point of Care Ultrasound (POCUS)
- Being tested
- Abdominal Point of Care Ultrasound
- Keywords
- Paracentesis, Point of Care Ultrasound (POCUS)
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Point of Care UltrasoundDiagnostic test
Participants will be have their needle insertion site for a paracentesis land-marked using both the traditional anatomical method, and with a point of care ultrasound. Note that the current standard of care does not require the use of point of care ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Not described Receives: Diagnostic Test: Abdominal Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of land-marking method
Does the clinician performing the procedure prefer the needle insertion site found using point of care ultrasound, or using the traditional anatomic method. A clinically significant difference in location is defined as greater than or equal to 5cm apart. If the difference in locations is not at least 5cm apart, this will be defined as no preference in land-marking methods.
Measured: Determined immediatly after the POCUS landmarking is done.
Secondary outcomes (2)
Depth of Ascitis
Depth of ascitis, measured perpendicular to the overlying skin, at the location land-marked using traditional anatomic method, versus the location found with point of care ultrasound.
Measured: Determined immediatly after the POCUS landmarking is done.
Immediate Complications
The overall rate of any complications observed while performing the procedure. This includes bleeding, perforation/puncture of any internal organ, or a failed attempt.
Measured: Occuring at any time between the needle insertion and removal of the paracentesis drain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start7 Feb 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Montague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven Montague, Queen's University
- Investigators
- Steven Montague, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245553
- Sponsor's protocol ID
- 6028481
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?
- ClinicalTrials.gov ID
- NCT04245553
- Acronym / sponsor ID
- 6028481
- Conditions
- Ascites, Paracentesis, Point of Care Ultrasound (POCUS)
- Keywords
- Paracentesis, Point of Care Ultrasound (POCUS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Steven MontagueUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Paracentesis is a bedside procedure in which a needle is inserted into a patient's peritoneum in order to obtain ascitic fluid. This is a safe bedside procedure with very low risks of complications that is usually performed using physical exam maneuvers to determine the site of needle insertion. Point of care ultrasound (POCUS) technology has improved the safety of central venous catheter insertion and thoracentesis, yet the data on safety in paracentesis is equivocal. In a practical study, we aim to determine if POCUS will change the needle insertion site over the traditional anatomic landmarking method. Operators will landmark for paracentesis using conventional physical exam and then utilize POCUS to determine if there is a more optimal site. The primary endpoint will be whether POCUS yielded a change in the needle insertion site, as defined by a location greater than 5cm from the anatomic site, at least 20% of the time. The results will further our understanding of POCUS in improving procedural safety, thereby adding to the currently limited literature on this topic. Furthermore, this study will inform residency training programs about the utility in POCUS training for paracentesis and may advocate for the availability of POCUS devices to physicians performing this procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Diagnostic Test: Abdominal Point of Care Ultrasound |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants scheduled to have either a diagnostic of therapeutic paracentesis.
- Participants can be either inpatients under the care of general internal medicine, or outpatients under the care of gastroenterology or general internal medicine.
- Operators will be recruited on a volunteer basis and will include medical residents or subspecialty fellows with knowledge of POCUS for paracentesis purposes, either through core residency programs or more advanced training.
Key exclusion criteria (7 listed)
- Loculated ascites
- Current anticoagulation
- Hemodynamic instability
- Bowel obstruction
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Point of Care UltrasoundParticipants will be have their needle insertion site for a paracentesis land-marked using both the traditional anatomical method, and with a point of care ultrasound. Note that the current standard of care does not require the use of point of care ultrasound. | Diagnostic test | All Participants |
Primary outcome
Preference of land-marking method
Time frame: Determined immediatly after the POCUS landmarking is done.
Does the clinician performing the procedure prefer the needle insertion site found using point of care ultrasound, or using the traditional anatomic method. A clinically significant difference in location is defined as greater than or equal to 5cm apart. If the difference in locations is not at least 5cm apart, this will be defined as no preference in land-marking methods.
2 secondary outcomes
Depth of Ascitis
Time frame: Determined immediatly after the POCUS landmarking is done.
Immediate Complications
Time frame: Occuring at any time between the needle insertion and removal of the paracentesis drain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Montague, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Point of Care Ultrasound in people with Ascites and Paracentesis, run by Steven Montague at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference of land-marking method (time frame: Determined immediatly after the POCUS landmarking is done.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.